Label: KINESYS ANALGESIC SPORT- methyl salicylate and menthol stick
- NDC Code(s): 61481-0020-1
- Packager: Wilc Healthcare Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 20, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- RECOMMENDED USE
- DURATION OF USE
- STORAGE AND HANDLING
- MEDICINAL INGREDIENTS (PER DOSE UNIT)
- NON-MEDICINAL INGREDIENTS
-
RECOMMENDED DOSE
Adults, adolescents
1-4 time(s) per day. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.
Children 2-12 years old
1-4 time(s) per day. Application should be supervised by an adult. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.
- CAUTIONS AND WARNINGS
- KNOWN ADVERSE REACTIONS
- PRINCIPAL DISPLAY PANEL - 50 g Cylinder Label
-
INGREDIENTS AND APPEARANCE
KINESYS ANALGESIC SPORT
methyl salicylate and menthol stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-0020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ALCOHOL (UNII: 3K9958V90M) SODIUM STEARATE (UNII: QU7E2XA9TG) WATER (UNII: 059QF0KO0R) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61481-0020-1 50 g in 1 CYLINDER; Type 0: Not a Combination Product 05/31/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 05/31/2012 Labeler - Wilc Healthcare Inc (203499140) Registrant - Wilc Healthcare Inc (203499140) Establishment Name Address ID/FEI Business Operations Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-0020)
